DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment to the claims, filed on October 20, 2025, is
acknowledged. This listing of the claims replaces all prior versions and listings of the
claims.
Claims 16-21 and 37-44 are pending.
Claims 1-15 and 22-36 are cancelled.
Applicant’s amendment to the specification, filed October 20, 2025, is acknowledged.
Applicant’s remarks filed October 20, 2025 in response to the non-final rejection mailed April 21, 2025, is acknowledged and have been fully considered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Restriction/Elections
In response to a requirement for restriction/election mailed January 3, 2025, applicant elected with traverse Group I (claim 16), drawn to a variant platelet membrane glycoprotein IIIa (GPIIIa) comprising the amino acids sequences set forth in SEQ ID NO: 26 or SEQ ID NO: 27, in the reply filed February 17, 2025.
The species election was withdrawn by the Examiner in the previous Office action.
Claims 17-21 are withdrawn from further consideration by the examiner, according to 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 16 and 37-44 are being examined on the merits.
Sequence Compliance
The objection to the specification is withdrawn in view of the amendment to the sequence incorporation statement at paragraph [0003] to report the size of the sequence listing file in bytes.
Claim Objections
Claim 39 is objected to for reciting “A composition comprising platelet membrane glycoprotein IIIa (GPIIIa) comprising the amino acid sequence set forth in SEQ ID No: 26 or SEQ ID NO: 27 linked to a substrate.” In the interest of improving claim form, the Office suggests amending the claim to recite “A composition comprising a platelet membrane glycoprotein IIIa (GPIIIa) linked to a substrate, wherein the GPIIIa comprises the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO: 27.”
Claim Rejections - 35 USC § 112(b)
The rejection of claim 16 for being indefinite because it is unclear as to the intended meaning of the phrase and what constitutes the intending meaning of “variant” is withdrawn in view of amendment to the claim to remove “variant.”
Claims 16, 37-38, 41, and 44 are newly rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 16 (claims 37-38 dependent therefrom) and 41 (claim 44 dependent therefrom) are newly rejected as indefinite for reciting “A platelet membrane glycoprotein IIIa (GPIIIa) comprising the amino acid sequence set forth in SEQ ID No: 26 or SEQ ID NO: 27, wherein the amino acid sequence further comprises a histidine at position 446 relative to SEQ ID NO: 26 or 27, “ and “The composition of claim 39, wherein the amino acid sequence further comprises a histidine at position 446 with regard to SEQ ID NO: 26 or 27,” respectively, which are unclear. It is unclear how the GPIIIa can comprise the amino acid sequence of SEQ ID NO: 26 or 27 and simultaneously comprise a substitution of proline to histidine at position 446 relative to SEQ ID NO: 26 or 27. In the interest of clarifying the claims, it is suggested to amend claim 16 to recite “A platelet membrane glycoprotein IIIa (GPIIIa) comprising the amino acid sequence set forth in SEQ ID No: 26 or SEQ ID NO: 27, except for a histidine at position 446 relative to SEQ ID NO: 26 or 27,” and to amend claim 41 to recite “A composition comprising a platelet membrane glycoprotein IIIa (GPIIIa) linked to a substrate, wherein the GPIIIa comprises the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO: 27, except for a substitution of proline with histidine at position 446 relative to SEQ ID NO: 26 or SEQ ID NO: 27.”
Claim Rejections - 35 USC § 112(a)
The rejection of claim 16 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is maintained. Newly added claims 37-38, 41, and 44 are included in the rejection. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
According to MPEP 2163.II.A.3.(a).ii), [s]atisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163.
Claims 16 (claims 37-38 dependent therefrom) is drawn to a genus of platelet membrane glycoprotein IIIa (GPIIIa) proteins comprising the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO:27, wherein the amino acid sequence further comprises a histidine at position 446 relative to SEQ ID NO: 26 or 27.
Claim 41 (claim 44 dependent therefrom) is drawn to a composition comprising a genus of platelet membrane glycoprotein IIIa (GPIIIa) comprising the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO: 27 linked to a substrate, wherein the amino acid sequence further comprises a histidine at position 446 with regard to SEQ ID NO: 26 or 27.
The transitional phrase “comprises” is inclusive and open-ended (MPEP 2111.03) and given a broadest reasonable interpretation, the recitation of “the amino acid sequence further comprises a histidine at position 446 of SEQ ID NO: 26 or 27” in claim 16 and the recitation of “the amino acid sequence further comprises a histidine at position 446 with regard to SEQ ID NO: 26 or 27” in claim 41 allows unlimited amino acid insertions, deletions, and substitutions relative to SEQ ID NO: 26 or 27 including substitution to histidine at position 446 relative to SEQ ID NO: 26 or 27.
Consequently, it is the Office’s position that the claimed genera of GPIIIa proteins of claims 16 and 41 have substantial variation because of the numerous permutations permitted.
However, the specification does not provide adequate written description to identify the broad genus of the claims because, inter alia, the specification does not disclose a correlation between the necessary structure of the polypeptide (e.g., which amino acids must be maintained and which may be substituted in a variant) and the claimed function to be maintained. It is noted that while the description of the ability of a claimed protein sequence may generically describe that protein molecule's function, it does not describe the molecule itself. For example, the specification fails to identify critical amino acids or subsequences within SEQ ID NO: 26 or 27 that must be retained in order to maintain the claimed functional activity. Consequently, the specification fails to describe the common attributes or structural characteristics that identify the members of this genus and because the genus of sequences is highly variable (i.e., each sequence has a unique structure; see MPEP 2434), the characteristics of the ability to function as a GPIIIa protein, is insufficient to describe the genus. Thus, the specification does not provide substantive evidence for possession of this large and variable genus, encompassing a massive number of partial structures claimed only by a functional characteristic because, without an art-recognized structure-function correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. Thus, disclosure of function alone is little more than a wish for possession and it does not satisfy the written description requirement; See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
Further, MPEP §2163 states that if a biomolecule is described only by a functional characteristic (as in the instant case), without any disclosed correlation between function and structure of the sequence (as in the instant case), it is not sufficient for written description purposes, even when accompanied by a method of obtaining the claimed sequences. MPEP §2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number to adequately describe a broad genus. For example, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus (e.g., see In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618). Furthermore, the disclosure of only one or two species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
In the instant case, the specification provides complete structural information for SEQ ID NO: 26 and 27, respectively, and neither comprises a histidine at position 446 The specification provides amino acid sequences with a histidine at position 446 (para [0022, 0094-0095, 00105]; Figure 5; SEQ ID NO: 38; Table 1). The specification does not provide actual reduction to practice of a GPIIIa amino with an amino acid sequence of SEQ ID NO: 26 and 27, with or without a histidine at position 446 relative to SEQ ID NO: 26 or 27, linked to a substrate. Accordingly, the specification also does not provide adequate written description to identify the broad and variable genus of the claims because, inter alia, it does not describe a sufficient number and/or a sufficient variety of representative species to reflect the variation within the genus.
Consequently, based on the lack of information within the specification, there is evidence that a representative number and a representative variety of the numerous sequence variants with both the claimed structural attributes and functional properties have not yet been identified. MPEP 2163 which states an adequate written description of a chemical invention requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed; see, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). Accordingly, it is the Office’s position that even one of skill in the art would not accept the disclosure of mice expressing a variant platelet membrane glycoprotein IIIa (GPIIIa) to SEQID NO: 26 or 27, as either a sufficient number and/or variety of “representative species” for all of the sequence variants, encompassed by the broad and variable generic claims. Therefore, it is the Office’s position that one of skill in the art would not conclude that Applicant was in possession of the entire genus.
Regarding the level of skill and knowledge in the art of amino acid mutation, an ordinary artisan understands that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes. Also, and ordinary artisan the unpredictability associated with amino acid mutations such that a mutation can cause significant structural changes and unexpected effects on the function of a polypeptide.
Therefore, the state of the art supports that even the skilled artisan requires guidance on the critical structures of the polypeptide and/or polynucleotide per se (e.g. its sequence and/or critical domains within its sequence) and therefore does not provide adequate written description support for which structural features of the polypeptide and/or polynucleotide would predictably retain their functional activity (i.e. the state of the art is not sufficient to identify which amino acids must be conserved in order to maintain the claimed functions).
Consequently, neither the specification nor the state of the art provides sufficient written description to support the genus encompassed by the claims. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.). Given the above analysis of the factors as a whole, which the courts have determined are critical in determining whether Applicant is in possession of or the specification supports the claimed invention, Applicant has not satisfied the requirements as set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 41 and 44 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 39 requires a composition comprising platelet membrane glycoprotein IIIa (GPIIIa) comprising the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO:27 linked to a substrate. However, the recitation of “the amino acid sequence further comprises a histidine at position 446 of SEQ ID NO: 26 or 27” in claim 41 (claim 44 dependent therefrom) requires a modification to the sequence of SEQ ID NO: 26 or 27 and allows unlimited amino acid insertions, deletions, and substitutions relative to SEQ ID NO: 26 or 27 outside of the histidine substitution. As such, claim 41 does not further limit claim 39. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16, 37-38, and 41 are newly rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more, as necessitated by applicants amendment to claim 16 wherein “variant” is removed and wherein the amino acid sequence comprises a histidine at position 446 relative to SEQ ID NO: 26 or 27” is added as well add the addition of new claims 37-38. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014.
Claim Interpretation: Claims 16, 37-38, are drawn to a platelet membrane glycoprotein IIIa (GPIIIa), or a composition comprising thereof, comprising the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO:27, wherein the amino acid sequence further comprises a histidine at position 446 relative to SEQ ID NO: 26 or 27.
The transitional phrase “comprises” is inclusive and open-ended (MPEP 2111.03) and given a broadest reasonable interpretation, the recitation of “the amino acid sequence further comprises a histidine at position 446 of SEQ ID NO: 26 or 27” in claim 16 allows unlimited amino acid insertions, deletions, and substitutions relative to SEQ ID NO: 26 or 27 including substitution to histidine at position 446 relative to SEQ ID NO: 26 or 27.
In view of this broad but reasonable interpretation, claims 16 and 37-38 encompass a naturally occurring human platelet membrane glycoprotein IIIa (GPIIIa) (e.g., GenPept Accession Number NP_000203, published October 21, 2018, obtained from <https://www.ncbi.nlm.nih.gov/protein/47078292?sat=47&satkey=9596>; cited on the attached Form PTO -892; hereafter “NP_000203”). NP_000203 teaches a GPIIIa amino acid sequence comprising a histidine at position 446 relative to instant SEQ ID NO: 26 (see sequence alignment below). NP_000203 comprises an amino acid leucine at position 33 relative to SEQ ID NO: 26.
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Regarding claims 37-38, NP_000203 comprises an amino acid leucine at position 33 relative to SEQ ID NO: 26, Taniue et al. (US 2010/0173292 A1; cited on the attached Form PTO-892; hereafter “Taniue”) teaches a Leu(33) polymorphism in GPIIIa constitutes the antigen HPA-1a antigen (para [0004]; Table 1), and Arnold (Blood, published July 18, 2013, Vol. 122, No. 3, p. 307-309; cited on the attached Form PTO-892; hereafter “Arnold”) teaches monoclonal B2G1 is a human anti-HPA-1a antibody (para [0004]; Table 1). Therefore, the GPIIIa taught by NP_000203 inherently comprises the antigen HPA-1a antigen and can be bound by B2G1 monoclonal antibody.
Regarding claim 41, Troesch et al. (Biochem. J., published 1990, Vol. 268, p. 129-133; cited on the attached Form PTO-892; hereafter “Troesch”) teaches glycoprotein IIIa (GPIIIa) is glycosylated (p. 130, col 1, para 3 – p. 130, col 2, para 2; Table 1). Therefore, the GPIIIa taught by NP_000203 would inherently be glycosylated and thus be coupled to a carbohydrate.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claims recite a naturally occurring polypeptide, which is considered to be a law of nature or a natural phenomenon (a natural product). Accordingly, the claims are directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claims only recite the product of nature and do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not provide any additional element different from their natural counterparts.
For these reasons, the claims are rejected under section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The rejection of claim 16 under 35 U.S.C. 102(a)(1) for being anticipated by ITB3_MOUSE (Uniprot; published September 12, 2018; entry version 166; cited on the Form PTO-892 mailed April 11, 2025; hereafter “ITB3_MOUSE”) is withdrawn because ITB3_MOUSE does not teach the newly amended claim limitations wherein “variant” is removed and wherein the amino acid sequence comprises a histidine at position 446 relative to SEQ ID NO: 26 or 27” is added.
Claims 16, 37-38, and 41 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taniue and as evidenced by Arnold and Troesch.
As amended, the claims are drawn to a platelet membrane glycoprotein IIIa (GPIIIa) comprising the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO:27, wherein the amino acid sequence further comprises a histidine at position 446 relative to SEQ ID NO: 26 or 27.
The transitional phrase “comprises” is inclusive and open-ended (MPEP 2111.03) and given a broadest reasonable interpretation, the recitation of “the amino acid sequence further comprises a histidine at position 446 of SEQ ID NO: 26 or 27” in claim 16 allows unlimited amino acid insertions, deletions, and substitutions relative to SEQ ID NO: 26 or 27 including substitution to histidine at position 446 relative to SEQ ID NO: 26 or 27.
Regarding claim 16, Taniue teaches a platelet membrane glycoprotein IIIa (GPIIIa) with a sequence identifier of SEQ ID NO: 2 comprising a histidine relative to instant SEQ ID NO: 26 (para [0002, 0027-0031; 0040-0045]; SEQ ID NO: 2; Claim 6-7; see sequence alignment below).
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Regarding claims 37-38, Taniue teaches the GPIIIa with a sequence identifier of SEQ ID NO: 2 has a histidine at position 33 in its own sequence and relative to SEQ ID NO: 26 (SEQ ID NO: 2; see sequence alignment above). Taniue teaches Leu(33) polymorphism in GPIIIa constitutes the antigen HPA-1a antigen (para [0004]; Table 1).
Arnold is cited in accordance with MPEP 2131.01.III to show monoclonal B2G1 is a human anti-HPA-1a antibody (p. 308, col 3, para 5). Therefore, the GPIIIa taught by Taniue inherently comprises the antigen HPA-1a antigen and can be bound by B2G1 monoclonal antibody.
Regarding claim 41, Troesch is cited in accordance with MPEP 2131.01.III to show glycoprotein IIIa (GPIIIa) is glycosylated (p. 130, col 1, para 3 – p. 130, col 2, para 2; Table 1). Therefore, the GPIIIa taught by NP_000203 would inherently be glycosylated and thus be coupled to a carbohydrate substrate.
For the reasons stated herein, claims 16, 37-38, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taniue as and evidenced by Arnold and Troesch.
Claim Rejections - 35 USC § 103
The rejection of claim 16 under 35 U.S.C. 103 for being unpatentable over ITB3_MOUSE in view Zhi et al. (Blood, 2015, 126 (23): 2340; cited on the Form PTO-892 mailed April 11, 2025; hereafter “Zhi”) is withdrawn because the recited prior art does not teach or suggest the newly amended claim limitations wherein “variant” is removed and wherein the amino acid sequence comprises a histidine at position 446 relative to SEQ ID NO: 26 or 27” is added.
The rejection claim 16 under 35 U.S.C. 103 for being unpatentable over ITB3_MOUSE in view of Zhi, as applied to claim 16, further in view of Ahlen et al. (T Blood, 2009, 113(16): 3838-3844; as cited in the IDS on 10/16/2023; hereafter “Ahlen”) and Springer et al. (US 2010/0167418 A1; cited on the Form PTO-892 mailed April 11, 2025; hereafter “Springer”) is withdrawn because the recited prior art does not teach or suggest the newly amended claim limitations wherein “variant” is removed and wherein the amino acid sequence comprises a histidine at position 446 relative to SEQ ID NO: 26 or 27” is added.
Claims 41 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Taniue, as applied to claims 16, and 41, 37-38 above, in view of Eksteen (published by UiT Norges Arktiske Universitet, published 2015; cited on the attached Form PTO-892; hereafter “Eksteen”) and Arnold, and as evidenced by Troesch.
As amended, the claims are drawn to a composition comprising a platelet membrane glycoprotein IIIa (GPIIIa) linked to a substrate, wherein the GPIIIa comprises the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO: 27, except for a substitution of proline with histidine at position 446 relative to SEQ ID NO: 26 or SEQ ID NO: 27.”
The transitional phrase “comprises” is inclusive and open-ended (MPEP 2111.03) and given a broadest reasonable interpretation, the recitation of “the amino acid sequence further comprises a histidine at position 446 of SEQ ID NO: 26 or 27” in claim 16 allows unlimited amino acid insertions, deletions, and substitutions relative to SEQ ID NO: 26 or 27 including substitution to histidine at position 446 relative to SEQ ID NO: 26 or 27.
Regarding claims 41, the relevant teachings of Taniue and evidentiary references Arnold as applied to claim 16 and 37-38, are discussed above and incorporated herein.
Taniue does not teach wherein the GPIIIa is linked to a substrate.
Allen teaches neonatal alloimmune thrombocytopenia (NAIT) is caused by maternal alloantibodies against fetal platelet antigens inherited from the father and which are absent from maternal platelets (p. X, para 1). Allen teaches antibodies against the Leu33 (HPA-1a) polymorphism of integrin β3 (also termed glycoprotein IIIa (GPIIIa); hereafter “GPIIIa) account for >70% of cases in Caucasians (p. X, para 1; Tables 1.1-1.2). Allen teaches coupling GPIIIa fragments expressing HPA-1a to screen HPA antibodies; including anti-HPA-1a antibodies; which allows which testing for platelet antibodies (p. 33, para 3).
In view of the combined teachings of Taniue and Allen, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to couple the GPIIIa taught by Taniue to microbeads to produce a composition capable of screening for anti-HPA-1a antibodies associated with NAIT, thereby arriving at the invention of claim 41.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success of coupling the GPIIIa taught by Taniue to microbeads to produce a composition since Allen taught fusing GPIIIa fragments with HPA-1a antigens in order screen for anti-HPA-1a antibodies associated with NAIT.
Regarding claim 44, the relevant teachings of Taniue and Allen and evidentiary reference Arnold as applied to claim 16, 37-38, and 41, are discussed above and incorporated herein.
The combination of Taniue and Allen doe not explicitly teach wherein the composition of GPIIIa also comprises
Allen further teaches results of an experiment can be non-reliable when an assay is missing a positive control (p. 63, para 2).
Arnold further teaches B2G1 is a human anti-HPA-1a monoclonal antibody (p. 308, col 3, para 5).
In view of the combined teachings of Taniue, Allen, and Arnold, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention modify the composition comprising GPIIIa coupled to microbeads taught by the combination of Taniue and Allen to include B2G1 anti-HPA-1a antibodies taught by Arnold, thereby arriving at the invention of claim 44.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success of coupling modifying the composition comprising GPIIIa coupled to microbeads taught by the combination of Taniue and Allen to include B2G1 anti-HPA-1a antibodies taught by Arnold in order to provide a positive control for a screen of patient blood samples for antibodies associated with NAIT.
Consequently, the invention of claims 41 and 44 would have been obvious to one of ordinary skill in the art before the effective filing date.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
As amended, claims 39-40 and 42-43 are drawn to a composition comprising GPIIIa comprising the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO: 27 linked to a substrate. The prior art of record does not teach or suggest a GPIIIa comprising the amino acid sequence set forth in SEQ ID NO: 26 or SEQ ID NO: 27. As such, the compositions comprising the GPIIIa of claims 39-40 and 42-43 are allowable over the prior art of record.
Conclusion
No claims are in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT E. MULDER whose telephone number is (571)272-2372. The examiner can normally be reached Monday - Friday 7:30 AM - 3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at (571) 272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT E. MULDER/Examiner, Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656